Enteer™ ENB-375-20-135Recalls & reported problems
Ev3, Inc · CATH ENB-375-20-135 CTO RE-ENTRY V03 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684073797), received between Jun 11, 2018 and Nov 13, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Damaged by Another Device2
- Burst Container or Vessel1
- Defective Device1
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2019Burst Container or Vessel; Inflation Problem; Defective Device; Device Damaged by Another Device; Burst Container or Vessel; Inflation Problem; Defective Device; Device Damaged by Another Device
PHYSICIAN WAS ATTEMPTING TO USE ENTEER GUIDE CATHETER. IT WAS REPORTED THAT CATHETER BROKE AND BALLOON BURST OCCURRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9315924 ↗MalfunctionJun 11, 2018Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT THE PHYSICIAN EMPLOYED THE USE OF AN ENTEER RE-ENTRY BALLOON CATHETER AND AN ENTEER RE-ENTRY GUIDEWIRE DURING TREATMENT OF A 250MM SEVERELY CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) LESION IN THE PATIENTS DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENTS AORTOILIAC BIFURCATION IS REPORTED TO HAVE BEEN SEVERELY TORTUOUS. THE IFU WAS FOLLOWED AND THE DEVICES WERE PREPPED WITHOUT ISSUE. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE ENTEER WAS ADVANCED IN A CONTRALATERAL FASHION VIA A 6FR 45CM SHEATH. THE ILIACS WERE REPORTED TO BE VERY TORTUOUS. THE ENTEER BALLOON REACHED THE TARGET SITE AND WAS INFLATED. IT IS REPORTED THAT DURING ADVANCEMENT OF THE ENTEER WIRE IT APPEARED TO GET CAUGHT MID CATHETER AND THE WIRE ENDED UP PUNCTURING THE BALLOON LUMEN WHICH RESULTED IN LOSS OF BALLOON PRESSURE. IT WAS REPORTED THAT THE ENTEER RE-ENTRY GUIDEWIRE WAS UNABLE TO ROTATE TORQUE BUT WAS EASILY WITHDRAWN. THE PHYSICIAN THEN USED A SECOND ENTEER RE-ENTRY BALLOON CATHETER AND AN ENTEER RE-ENTRY GUIDEWIRE TO ATTEMPT TREATMENT, BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN WAS UNABLE TO RE-ENTER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7586264 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.